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Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery)

Study acronym: FORGE II
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv7 Show 4 more changesShow less
    • Primary completion date: Sep 30, 2025 to Dec 30, 2026
    • Start date changed from estimate of Sep 1, 2024 to Apr 8, 2025
    • Study completion date: Dec 30, 2025 to Dec 30, 2026
    • Study site revised
  2. Start date: Feb 1, 2024 to Sep 1, 2024
    • Site contact updated
    v6
  3. Primary completion date: Oct 30, 2025 to Sep 30, 2025v5
  4. Primary completion date: Oct 30, 2023 to Oct 30, 2025
    • Start date: Jun 1, 2023 to Feb 1, 2024
    • Study completion date: Dec 30, 2023 to Dec 30, 2025
    • Site contact updated
    v4
  5. Re-verified, no change to tracked fieldsv3
  6. Start date: Sep 1, 2022 to Jun 1, 2023v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Iron deficiency has been reported in approximately 35% of patients with a gynecologic malignancy. Blood transfusions are known to be immunosuppressive and carry immediate and long-term risks. Pre-operative blood transfusion in gynecologic oncology patients is associated with higher rates of surgical site infection, length of stay, composite morbidity, cancer recurrence, and mortality. Pre-operative intravenous iron formulations have been shown in benign gynecology and other surgical specialities to increase pre-operative hemoglobin and decrease post-operative transfusion rates. This is a randomized double-blinded clinical trial evaluating the effects of treating patients undergoing gynecologic oncology surgery with intravenous ferric derisomaltose to correct pre-operative iron-deficiency anemia. The study aims to assess the effectiveness of preoperative ferric derisomaltose/iron isomaltoside compared to placebo in correcting preoperative hemoglobin in patients undergoing surgery for gynecologic malignancy.
Trial Details
NCT Number NCT05407987
Lead Sponsor AHS Cancer Control Alberta
Conditions
(from sponsor)		 Gynecologic Cancer, Anemia, Iron-deficiency
Related terms Anemia, Anemia, Iron-Deficiency
Enrollment 82 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov